March 16, 2021
Moderna has begun testing its COVID-19 vaccine on children as young as six months old, making it the first company to enroll infants and toddlers in a clinical trial for a coronavirus shot.
The study, dubbed KidCOVE, aims to enroll 6,750 healthy participants under 12 years old in the United States and Canada, the company said Tuesday. The first doses of the trial already have been administered.
The Children's Hospital of Philadelphia has been selected as a site for the trial, according to a spokesperson. The hospital will start enrolling children in the trial in the coming weeks.
CHOP's Vaccine and Treatment Evaluation Unit has an online survey that parents can fill out if they are interested in potentially enrolling their children in COVID-19 vaccine studies. But the hospital has not yet released enrollment instructions and criteria specific to the Moderna study.
In the Moderna study, each participant will receive two shots administered 28 days apart — the same duration in which they are being given to adults. In the trials' first stage, children ages 2-12 will either receive two doses of 50 or 100 micrograms. Infants may receive two doses of 25, 50 or 100 micrograms.
In adults, the vaccine has been authorized by the U.S. Food and Drug Administration to be given in 100 microgram doses.
The first children enrolled in the trial will receive the lowest doses. They will be monitored for symptoms and reactions. An interim analysis will determine which dose is the safest and most effective for each age group. In the study's second stage, children will receive the doses identified during the analysis or a placebo.
Moderna CEO Stéphane Bancel said the company has been encouraged by the success of the company's vaccine in adults. More than 53 million doses have been administered to people in the U.S. The pediatric study will help assess the "potential safety and immunogenicity" of the vaccine in children, she said.
The children involved in the study will be monitored for 12 months to measure antibody levels and symptoms.
Moderna already is testing its vaccine on 3,000 children ages 12-17 in a separate study. The results are expected to come in over the summer. Pfizer and Johnson & Johnson also have launched pediatric trials for their COVID-19 vaccines, but none of them include children younger than age 12.
The American Academy of Pediatrics has backed the expansion of vaccine trials to include children. It previously advised children 16 and older to get the Pfizer vaccine, the only coronavirus shot authorized for some children.
"Trials in children must keep pace with the tremendous amount of data being generated in adult trials, and this should be initiated safely and as soon as possible so there could be a vaccine authorized for younger children before the next school year begins," AAP President Dr. Sara Goza said after the FDA authorized the Pfizer vaccine last year.
But not everyone is convinced such a fast pace is necessary.
Dr. David Wohl, the medical director of the vaccine clinic at the University of North Carolina, told the New York Times that he was surprised Moderna was going ahead with trials involving infants and toddlers.
"Should we learn first what happens in the older kids before we go to the really young kids?" Dr. Wohl said. Most children don't develop severe COVID-19 symptoms, though some developed a severe inflammatory syndrome.
Doctors say vaccine side effects like fever, sore arm, fatigue and achy joints can be stronger in children than adults.
Moderna developed its vaccine study with the National Institute of Allergy and Infectious Diseases and the federal Biomedical Advanced Research and Development Authority.